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NCT01033682 Clinical Trial

Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging

Rectal Cancer Clinical Trial

— FILL  

Official title:
Evaluation of Bladder Volumes in Patients Receiving Radiotherapy to the Rectum, Using Kilovoltage Cone-beam Imaging

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01033682
Other study ID # CCR3175
Secondary ID
Status Recruiting
Phase N/A
First received December 15, 2009
Last updated December 15, 2009
Start date May 2009
Est. completion date February 2010

Study information
Verified date December 2009
Source Royal Marsden NHS Foundation Trust
Contact Dr Diana Tait
Phone 02086613365
Email diana.tait@rmh.nhs.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to implement and access a newly developed bladder filling protocol for patients receiving radiotherapy for rectal cancer using imaging on the treatment unit.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients receiving radical radiotherapy to rectal malignancies.

- Age > 18 years old

- No previous lower GI radiotherapy

- Written informed consent according to good clinical practice (GCP) and national / local regulations.

Exclusion Criteria:

- Patients receiving palliative radiotherapy to rectal malignancies.

- Patients receiving radical short course preoperative radiotherapy for rectal malignancies.

- Patients unable to give informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Royal Marsden NHS Foundation Trust Sutton Surrey

Sponsors (1)
Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of patients who are able to achieve a bladder volume within +/- 30% of planning volume, on all treatment CBCT (cone beam computed tomography) scans No
Secondary The per-patient standard deviation of bladder volume throughout the course of radiotherapy No
Secondary The percentage of patients who are unable to follow the bladder filling protocol at any point during their treatment. No
Secondary The correlation between bladder volume and small bowel volume planning target volume No
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